FDA 510(k)

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Número K: K251495 · 2025-08-13

RequerenteBruker Daltonics GmbH & Co. KG

Data da decisão2025-08-13

Código do produtoQBN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MBT Compass HT CA Software; MBT FAST Shuttle US IVD is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K251495. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.

When did MBT Compass HT CA Software; MBT FAST Shuttle US IVD receive FDA 510(k) clearance?

MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251495.

Who is the listed applicant for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

The FDA 510(k) record lists Bruker Daltonics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

The FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD is QBN.

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